AnxietySTRESSCOMNCT03849976
Therapeutic Communication Training of the Stretcher Bearers on the Patient Anxiety (STRESSCOM)
An observational study of Anxiety, run by Lille Catholic University at 1 site in France.
Trial summary
Anxiety is a form of psychic and/or physical discomfort caused by the feeling of the imminence of a danger. It is a frequent perioperative manifestation of patients. Pharmacological premedication is currently used to avoid perioperative anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Therapeutic communication
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2018to 17 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients in ambulatory sector for endoscopic examination under general anesthesia.
Who may be able to join
- Major patients
- Hospitalized in the ambulatory sector for endoscopic examination under general anesthesia (fibroscopy/colonoscopy/others)
- Able to answer anxiety questionnaires
- Able to walk to the operating room according to the usual practice (no motor disorder)
- Not presenting a psychiatric or cognitive disorder, or a non-paired hearing disorder that may interfere with therapeutic communication
- Being informed and not being opposed
Who cannot join
- Refusal to participate in the study
- Patients under guardianship
- Patient who received premedication before going down to the operating room (benzodiazepines, gabapentin, antihistamines)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of the Therapeutic Communication Training of the Stretcher Bearers on the Patient Anxiety in the Operating Room (STRESSCOM)
Anxiety is a form of psychic and/or physical discomfort caused by the feeling of the imminence of a danger. It is a frequent perioperative manifestation of patients. Pharmacological premedication is currently used to avoid perioperative anxiety. However, its effect is now controversial and non-drug techniques have been also studied.
The therapeutic communication aims to provide analgesia or anxiolysis to enhance the patient's well-being and to separate the patient from the surrounding reality through the suggestion of positive images with a chosen verbal and nonverbal approach. This prospective, monocentric, comparative, double-blind study aims to evaluate the impact of the training of stretcher-bearers in therapeutic communication on the anxiety of patients who go to the operating room for an endoscopic examination under general anaesthesia.Two groups of patients will be compared: In the first group patients will be accompanied to the operating room by a stretcher-bearer trained in therapeutic communication, in the second group patients will be accompanied by a stretcher bearer without this specific training.
Read the detailed description
Anxiety is a form of psychic and/or physical discomfort caused by the feeling of the imminence of a danger. It is a normal reaction of adaptation and defense face to a situation lived as hostile. It is a frequent perioperative manifestation. Patients who need an intervention are indeed 20% more anxious than the general population. The occurrence of this anxiety can have consequences for perioperative medical care influencing morbidity and mortality.
Pharmacological premedication initially prescribed in the 19th century to limit the adverse effects of general anesthesia is currently used to fight perioperative anxiety. However, its effects are now considered as controversial.
and non-drug techniques have been studied. They have the advantage of being inexpensive and causing little or no adverse effects.
Therapeutic communication can be defined as a relational technique that seeks to separate the patient from the surrounding reality to provide analgesia or anxiolysis through the suggestion of positive images with a chosen verbal and nonverbal approach.
The knowledge of communication techniques resulting from hypnosis by the healthcare team could therefore optimize patient medical care in terms of analgesia and the management of perioperative anxiety. Therapeutic communication training in the operating room is short and accessible to all members of the team regardless of their rank. This is a training provided internally by a certified practitioner in therapeutic hypnosis, aiming to give to the professionals knowledge to optimize the patient support. At the hospital (Groupement des Hôpitaux de l'Institut Catholique de Lille), several stretcher bearers have been trained in therapeutic communication and are already applying it routinely.
No study has yet investigated the impact of the use of therapeutic communication in the operating room to control the level of anxiety of patients.
This study is prospective, monocentric, comparative, double blind. Two groups of patients will be compared: In the first group patients will be accompanied to the operating room by a stretcher-bearer trained in therapeutic communication, in the second group patients will be accompanied by a stretcher bearer without this specific training.
- Conditions
- Anxiety
- Being tested
- Therapeutic communication
- Keywords
- Therapeutic communication, Anxiety, Endoscopic examination under general anesthesia, Operating room, Stretcher bearer
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic communicationBehavioural
Patients will be accompanied to the operating room by a stretcher bearer trained in therapeutic communication
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Patients accompanied to the operating room by a stretcher bearer trained in therapeutic communication Receives: Behavioral: Therapeutic communication | |
| Control group | Patients accompanied to the operating room by a stretcher bearer not trained in therapeutic communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety scale: State-Trait Anxiety Inventory (STAI-Y), form A
This scale is composed of 20 propositions to know how the subject feels. Each item has a score from 1 to 4 (4 being the highest degree of anxiety). The score therefore varies from 20 to 80.
Measured: Day one (before intervention)
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
The APAIS questionnaire includes 6 questions, 2 of which evaluate the patient's anxiety about anesthesia, 2 questions estimate the anxiety about the procedure, the last 2 questions evaluate the patient's need for information about anesthesia and the procedure. Each question is rated from 1 to 5, the scale allows to calculate 4 scores (anesthetic anxiety/intervention anxiety/global and information request score). Subjects are considered anxious when they have a score higher than 11 for these 4 items.
Measured: Day one (before intervention)
Secondary outcomes (2)
Evaluation of the experience of general anesthesia (EVAN-G) scale
EVAN-G questionnaire includes 26 questions. Results are grouped together to define 6 "dimensions": Focus of attention, Information, Privacy, Pain, Discomfort and Waiting Times. From these scores, an overall satisfaction score is calculated (average of all scores). For each of the scores: the higher the score, the higher the satisfaction.
Measured: In average one day (at hospital discharge)
Likert scale
Patient cooperation: evaluated by the nurse anesthesiologist with a Likert scale rated from 1 (no cooperation) to 5 (excellent cooperation).
Measured: Day one (at the end of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start25 Oct 2018
- Primary completion17 Dec 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Christophe Canevet, Principal investigator, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849976
- Sponsor's protocol ID
- RC-P0075
- Acronym
- STRESSCOM
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2019
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the Therapeutic Communication Training of the Stretcher Bearers on the Patient Anxiety in the Operating Room (STRESSCOM)
- ClinicalTrials.gov ID
- NCT03849976
- Acronym / sponsor ID
- STRESSCOM / RC-P0075
- Conditions
- Anxiety
- Keywords
- Therapeutic communication, Anxiety, Endoscopic examination under general anesthesia, Operating room, Stretcher bearer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anxiety is a form of psychic and/or physical discomfort caused by the feeling of the imminence of a danger. It is a frequent perioperative manifestation of patients. Pharmacological premedication is currently used to avoid perioperative anxiety. However, its effect is now controversial and non-drug techniques have been also studied.
The therapeutic communication aims to provide analgesia or anxiolysis to enhance the patient's well-being and to separate the patient from the surrounding reality through the suggestion of positive images with a chosen verbal and nonverbal approach. This prospective, monocentric, comparative, double-blind study aims to evaluate the impact of the training of stretcher-bearers in therapeutic communication on the anxiety of patients who go to the operating room for an endoscopic examination under general anaesthesia.Two groups of patients will be compared: In the first group patients will be accompanied to the operating room by a stretcher-bearer trained in therapeutic communication, in the second group patients will be accompanied by a stretcher bearer without this specific training.
Detailed description
Anxiety is a form of psychic and/or physical discomfort caused by the feeling of the imminence of a danger. It is a normal reaction of adaptation and defense face to a situation lived as hostile. It is a frequent perioperative manifestation. Patients who need an intervention are indeed 20% more anxious than the general population. The occurrence of this anxiety can have consequences for perioperative medical care influencing morbidity and mortality.
Pharmacological premedication initially prescribed in the 19th century to limit the adverse effects of general anesthesia is currently used to fight perioperative anxiety. However, its effects are now considered as controversial.
and non-drug techniques have been studied. They have the advantage of being inexpensive and causing little or no adverse effects.
Therapeutic communication can be defined as a relational technique that seeks to separate the patient from the surrounding reality to provide analgesia or anxiolysis through the suggestion of positive images with a chosen verbal and nonverbal approach.
The knowledge of communication techniques resulting from hypnosis by the healthcare team could therefore optimize patient medical care in terms of analgesia and the management of perioperative anxiety. Therapeutic communication training in the operating room is short and accessible to all members of the team regardless of their rank. This is a training provided internally by a certified practitioner in therapeutic hypnosis, aiming to give to the professionals knowledge to optimize the patient support. At the hospital (Groupement des Hôpitaux de l'Institut Catholique de Lille), several stretcher bearers have been trained in therapeutic communication and are already applying it routinely.
No study has yet investigated the impact of the use of therapeutic communication in the operating room to control the level of anxiety of patients.
This study is prospective, monocentric, comparative, double blind. Two groups of patients will be compared: In the first group patients will be accompanied to the operating room by a stretcher-bearer trained in therapeutic communication, in the second group patients will be accompanied by a stretcher bearer without this specific training.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Behavioral: Therapeutic communicationPatients accompanied to the operating room by a stretcher bearer trained in therapeutic communication |
| Control group | – | –Patients accompanied to the operating room by a stretcher bearer not trained in therapeutic communication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients in ambulatory sector for endoscopic examination under general anesthesia.
Key inclusion criteria (6 listed)
- Major patients
- Hospitalized in the ambulatory sector for endoscopic examination under general anesthesia (fibroscopy/colonoscopy/others)
- Able to answer anxiety questionnaires
- Able to walk to the operating room according to the usual practice (no motor disorder)
- Not presenting a psychiatric or cognitive disorder, or a non-paired hearing disorder that may interfere with therapeutic communication
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Patients under guardianship
- Patient who received premedication before going down to the operating room (benzodiazepines, gabapentin, antihistamines)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic communicationPatients will be accompanied to the operating room by a stretcher bearer trained in therapeutic communication | Behavioural | Experimental group |
Primary outcome
Anxiety scale: State-Trait Anxiety Inventory (STAI-Y), form A
Time frame: Day one (before intervention)
This scale is composed of 20 propositions to know how the subject feels. Each item has a score from 1 to 4 (4 being the highest degree of anxiety). The score therefore varies from 20 to 80.
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: Day one (before intervention)
The APAIS questionnaire includes 6 questions, 2 of which evaluate the patient's anxiety about anesthesia, 2 questions estimate the anxiety about the procedure, the last 2 questions evaluate the patient's need for information about anesthesia and the procedure. Each question is rated from 1 to 5, the scale allows to calculate 4 scores (anesthetic anxiety/intervention anxiety/global and information request score). Subjects are considered anxious when they have a score higher than 11 for these 4 items.
2 secondary outcomes
Evaluation of the experience of general anesthesia (EVAN-G) scale
Time frame: In average one day (at hospital discharge)
Likert scale
Time frame: Day one (at the end of the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Canevet principal investigator
Lille Catholic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Lille Catholic University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety scale: State-Trait Anxiety Inventory (STAI-Y), form A (time frame: Day one (before intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.